7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
FDA 510(k)
FDA Class 2
·Orthopedic
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
REMB UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·June 30, 2011
CENTRICITY RA1000
FDA Adverse Event
Malfunction
·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·September 1, 2008
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024